Kornimate/medical-research-clean huggingface dataset:
a study of the relative bioavailability of bms-626529 administered as bms-663068 from 150mg low-dose extended-release tablets compared to 600mg reference extended-release tablets in healthy subjects

Conditions: Infection, Human Immunodeficiency Virus

Summary: an oral dose in healthy subjects to determine the relative bioavailabilty of bms-626529 administered as bms-663068


Eligibility criteria:
inclusion criteria: 1. signed informed consent 2. target population: healthy subjects as determined by no clinically significant deviation from normal in medical and surgical history, physical examination, vital sign measurements, 12-lead ecg measurements and clinical laboratory test results. body mass index (bmi) of 18.0 to 32.0 kg/m². 3. subject re-enrollment: this study permits the re-enrollment of a subject that has discontinued the study as a pre-treatment failure (i.e., subject has not been randomized/ has not been treated). if re-enrolled, the subject must be re-consented. 4. age: males and females, ages 18 or age of majority to 50 years, inclusive. 5. reproductive status: women of childbearing potential (wocbp) must have a negative serum/urine (urine test not allowed at screening and day -1 of period 1) pregnancy test (minimum sensitivity 25 iu/l or equivalent units of human chorionic gonadotropin) within 24 hours prior to the start of study drug. women must not be breastfeeding. women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug plus 5 half-lives of study drug (60 hours) plus 30 days (duration of ovulatory cycle) for a total of 33 days post-treatment completion. males who are sexually active with wocbp must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug plus 5 half-lives of study drug (60 hours). in addition, male subjects must be willing to refrain from sperm donation during this time. azoospermic males are exempt from contraceptive requirements. women of childbearing potential who are continuously not heterosexually active are also exempt from contraceptive requirements, and still undergo pregnancy testing as described in this section. exclusion criteria: 1. medical history and concurrent diseases: history of any chronic or acute illness, gastrointestinal disease, gastrointestinal surgery within less than 4 weeks of dosing, blood donation within 4 weeks of dosing, blood transfusion within 4 weeks of dosing, smoking within less than 12 months prior to dosing, alcohol abuse, inability to tolerate oral medication, or inability to be venipunctured. any other sound medical, psychiatric and/or social reason as determined by the investigator. 2. physical and laboratory test findings: evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs measurements, ecgs, or clinical laboratory determinations beyond what is consistent with the target population. 3. exposure to any investigational drug or placebo within 4 weeks of study drug administration.
the hifub study (hifu in breast cancer)

Conditions: Breast Cancer

Summary: high intensity focused ultrasound (hifu) is a new method of treating solid tumours by thermally ablating them. it has been used in a number of different types of cancers but there is little information on its use in invasive breast cancer (ibc). the investigators aim to assess the efficacy and safety of hifu in the treatment of ibc. in this study, fifteen otherwise healthy women diagnosed with small, early stage ibc will be treated with hifu prior to conventional surgical treatment. the effects of hifu on the resected tumour will be analysed pathologically and correlated with radiological findings. immune response and participant experience will also be evaluated


Eligibility criteria:
inclusion criteria: * participant is willing and able to give informed consent for participation in the trial. * female, aged 18 years or above. * histologically confirmed breast cancer (invasive ductal cancer) by core biopsy, which is suitable for surgical resection. * participants must have one non-metastatic, clinically palpable, invasive breast cancer measuring ≤2cm in its largest dimension, which can be visualised using diagnostic ultrasound. * all participants must have an adequate biopsy determination of oestrogen, progesterone, her2 receptor status on pre-operative biopsy. * adequate ecg, haematological, renal and hepatic function, as indicated, as would be required for imaging and surgery. * in the investigator's opinion, is able and willing to comply with all trial requirements. exclusion criteria: * female participant who is pregnant. * significant renal or hepatic impairment. * an inadequate biopsy determination of oestrogen, progesterone, her2 receptor status on pre-operative biopsy. * unable to visualize lesion or tumour boundaries clearly on ultrasound. * subjects with tumours lying less than 5mm to overlying skin or less than 5mm to the underlying muscle on the diagnostic scan. * any uncontrolled illness or any other medical problem that would preclude surgery. * the presence of any contraindication for magnetic resonance imaging, e.g. the presence of a heart pacemaker, a metallic foreign body (metal sliver) in the eye, or an aneurysm clip in the brain or severe claustrophobia.

Keywords: breast cancer high intensity frequency ultrasound
fatty acid antiarrhythmia trial (faat)

Conditions: Arrhythmia; Heart Diseases; Tachycardia, Ventricular; Ventricular Fibrillation

Summary: to determine if the dietary n-3 class of polyunsaturated fatty acids (pufas) provided in the diet largely from marine fish oils would prevent fatal ventricular tachycardia (vt) or ventricular fibrillation (vf).

background: sudden death is a common manifestation of ischemic heart disease and therefore of great public health concern. unfortunately several promising antiarrhythmic drugs proved not to be effective in preventing sudden deaths. this project would test whether a relatively inexpensive and presumably innocuous therapy, fish oil supplements, can prevent life-threatening arrhythmias. there is ample basic evidence that n-3 fatty acids contained in fish oil supplements may suppress arrhythmias, and a clinical trial seems warranted. design narrative: prospective, randomized, placebo-controlled, double-blind. patients were randomized to 4 grams per day of a pufa fish oil supplement versus an olive oil placebo. the number of therapeutic discharges were recorded from the icds and then confirmed from the recorded electrocardiogram strips with the kinds of arrhythmias which had induced the icd response. the primary end point, time to first icd event for ventricular tachycardia or fibrillation (vt or vf) confirmed by stored electrograms or death from any cause, was analyzed by intention to treat. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
a pilot study to evaluate the efficacy of itdd vs. cmm in the treatment of pancreatic cancer pain

Conditions: Pain Management; Cancer Pain

Summary: the purpose of this study is to compare efficacy of pain treatment with itdd to efficacy of pain treatment with cmm in patients with pancreatic cancer pain.

this study is a non-randomized, open-label, single-center study that will compare efficacy of pain treatment with itdd to efficacy of pain treatment with cmm in patients suffering from pancreatic cancer pain. there will be two treatment groups: study group (itdd): these subjects will have a prometra system implanted and managed with the appropriate drug regimen to treat their pain. systemic analgesics will not be prescribed for this group. control group (cmm): these subjects will be treated with cmm to treat their pain. a maximum of 30 subjects (maximum of 15 in each treatment group) may be enrolled in this study at one study center.

Eligibility criteria:
inclusion criteria: 1. patient has stage iv pancreatic cancer. 2. patient agrees not to be treated by other oncologists or anesthesiologists during the study. 3. patient agrees not to obtain pain medications from other physicians during the study. 4. patient is at least 22 years of age. 5. investigator considers the patient to be able and willing to fulfill all study requirements. 6. patient is able to understand the study and provide written informed consent to participate in the study. exclusion criteria: 1. patient meets any of the contraindications for use of the prometra programmable infusion system (for patients in the itdd group). 2. patient is enrolled in another clinical study.

Keywords: cancer pain intrathecal therapy pain pancreatic cancer
study on recurrent breast cancer and repeated radiation therapy

Conditions: Recurrent Breast Carcinoma

Summary: this study explores whether recurrent breast cancer can be safely treated with breast-conserving surgery and repeated radiation therapy in cases where patients have previously undergone radiation. traditionally, recurrent breast cancer has been treated by removing the entire breast. however, recent research has shown that in certain situations, it may be possible to preserve the breast. the study will collect data on the safety of this treatment approach and its effects on patients. the treatment follows standard breast cancer care practices, involving 30 patients from helsinki and turku university hospitals. patients are carefully selected based on specific criteria, such as tumor size, localization, and prior treatment history. special attention is given to the planning of radiation therapy and surgical techniques. the goal is to develop new treatment strategies that allow breast preservation even in cases of recurrent breast cancer, providing patients with high-quality and individualized care.


Eligibility criteria:
inclusion criteria: * the patient has a diagnosed breast cancer or tumor area in the breast with a maximum diameter of 3 cm, where a previous breast-conserving surgery has been performed (either invasive breast cancer or carcinoma in situ, dcis). the patient has only a local recurrence, and imaging studies show no suspicion of metastases outside the breast (preoperative staging n0m0). at least 3 years have passed since the completion of prior radiation therapy. the new breast cancer can be technically treated with another breast-conserving surgery using a technique that does not require tissue transfer from areas opposite the removed tumor to restore the shape of the breast. the patient is at least 55 years old at the time of surgery. the patient is willing to participate in the study. the patient is capable of providing informed consent. exclusion criteria: * a booster dose, also known as a "boost," was administered during prior radiation therapy. preoperative assessments suggest multifocal breast cancer, with the tumor area to be removed exceeding 3 cm. the planned radiation therapy per the study protocol cannot be administered due to factors such as shoulder joint stiffness, a pacemaker located in the radiation field, or a skin condition (e.g., scleroderma). the patient is unable to provide informed consent or is unwilling to participate in the study. metastases outside the breast (e.g., axillary or distant metastases) are present.

Keywords: breast cancer recurrence repeat radiation therapy radiation therapy
telephone interview of patients that participated in the the pivotal betaferon ms trial.

Conditions: Multiple Sclerosis

Summary: the purpose of this study is to investigate the clinical status of patients who participated in the original pivotal betaseron study at 20 years after randomized treatment initiationstudy end-points include: 1. mortality - all-cause mortality - cause specific mortality - multiple sclerosis-related mortality 2. edss (expanded disability status scale) 3. cognition 4. resource use 5. spms (secondary progressive multiple sclerosis) status 6. employment history


Eligibility criteria:
inclusion criteria: * previously enrolled in the betaseron pivotal study protocols tb01-35686 in the us and tb01-35886 in canada (total, n=372) * patient, caregiver, or legal guardian must provide written informed consent * patient must confirm her/his ability and agreement to participate in the study at the beginning of the phone call
influence of gut hormones on food intake after roux-en-y gastric bypass surgery

Conditions: Severe Obesity

Summary: the aim of this study is to examine the effect of glp-1 and other gut-secreted hormones (glucagon, gip, grelin and pyy) on food-intake, appetite and glucose metabolism after roux-en-y gastric bypass surgery.

to do this the effect of combined glp-1 receptor blockade by exendin 9-39 and dpp-4-inhibition will be evaluated.

Eligibility criteria:
inclusion criteria: * uncomplicated rygb performed 3-12 month proir to the study. fasting plasma glucose \<7.0 mm and hba1c \< 48 mmol/mol 3 month after rygb. exclusion criteria: * fasting plasma glucose \>7.0 mm and hba1c \> 48 mmol/mol 3 month after rygb. hemoglobin \<6.5mm. previous anaphylaxis when treated with januvia or byetta. allergy for sitagliptin. dysregulated hypothyroidism. use of antithyroid treatment. late diabetic complications as retinopathy, renal insuffiency, neuropathy or previous pancreatitis. bad compliance. * complications to rygb: documented reactive hypoglycaemia, severe dumping (with vomiting, diarrhea or severe abdominal pain after food intake).
treatment of patients with nocturia

Conditions: Nocturia

Summary: the purpose of this study is to evaluate a treatment of nocturia. the hypothesis is that ser120 will decrease the number of nocturic episodes compared to placebo.


Eligibility criteria:
inclusion criteria: * male and female 50 years or older * nocturia of 6 or more months duration averaging 2 episodes or more per night exclusion criteria: * chf * diabetes * diabetes insipidus * renal insufficiency * hepatic insufficiency * incontinence * illness requiring steroids * current or past urologic malignancy * nephrotic syndrome * unexplained pelvic masses * urinary bladder neurological dysfunction * urinary bladder surgery or radiotherapy * sleep apnea * pregnant or breast feeding
tight glycaemic control during cardiac surgery

Conditions: Nosocomial Infection; External Causes of Morbidity and Mortality; Hypoglycemia

Summary: to determine whether intraoperative tight glycaemic control can reduce postoperative infection, morbidity and mortality

hyperglycaemia develops frequently in patients undergoing cardiac surgery, especially following cardiopulmonary bypass (cpb). recent evidence suggests that acute hyperglycaemia adversely affects immune function, wound healing and cardiovascular function.

Eligibility criteria:
inclusion criteria: * age \> 15 years * cardiac surgery with cardiopulmonary bypass exclusion criteria: * active infection * insulin allergy * off-pump cardiopulmonary bypass procedures

Keywords: tight glycemic control cardiac surgery
use of nac in prevention of hangover symptoms; independent alcohol consumption protocol

Conditions: Prevention of Hangover Using N-Acety Cysteine

Summary: this is a double-blinded study involving healthy non-alcoholic (self-reported) volunteers over the age of 21. consent is obtained prior to participation in the study while the participant is sober. volunteers are recruited from residency programs, hospital employees, emergency medical personnel, and friends of the study investigators. if the volunteers choose to drink, they can participate in the study the night of ingestion of alcohol. there is no amount we ask them to drink, and we allow them to withdraw from the study at any time. we never force them to drink alcohol, or even encourage it. the participation is completely voluntary, if they would like to participate and if they choose to drink alcohol, we ask them to participate in the placebo controlled study in the safety of their own home. then materials for the study are given out prior to their participation. an envelope is given with the questionnaire, and a small packet containing 3 pills of either nac or placebo, and a small smear of vicks vapor rub concealed in a small packet. at the end of their alcohol ingestion, the volunteer is asked to estimate the number roof drinks consumed and take 1 capsule per 3 drinks consumed of either 600 mg n-acetyl-l-cysteine or placebo capsules. in the morning, each participant fills out a hangover symptom score questionnaire . a random number generator is used to determine placebo or nac first, then the participant is given the other treatment at their subsequent encounter. then study is being conducted over a series of many months, and data can be analyzed by the hangover symptoms scale data when using nac compared to placebo. the data will be analyzed using the numerical values of each category for hangover classification and compare the placebo data to the control data.


Eligibility criteria:
inclusion criteria: * age over 21 years * able and agrees to drink alcohol exclusion criteria: * alcoholism (self-reported) * pregnancy * reactive airway disease * diabetes * kidney/bladder stones * kidney disease * liver disease * stomach ulcer * organ transplant patients * dialysis patients * allergies to alcohol, eggs, milk, or wheat * volunteers taking the following medications: opiate pain medication, activated charcoal, ampicillin,carbamazepine, cephalosporidine, methicillin, nitroglycerine, oxacillin, penicillin g, quinicillin

Keywords: hangovers n-acetyl cysteine alcohol
relative bioavailability study to compare inhalation of terbutaline sulphate 1,5mg via turbuhaler m3 with turbuhaler m2

Conditions: Healthy Volunteers

Summary: relative bioavailability study to compare inhalation of terbutaline sulphate 1,5mg via current version of turbuhaler with inhalation via a new version

an open-label, single-dose, 2-period cross over study in healthy male and female volunteers to assess relative bioavailability of terbutaline sulphate 1.5 mg after inhalation via the m3 turbuhaler (new version) compared with the m2 turbuhaler (current version)

Eligibility criteria:
inclusion criteria: 1. female and male volunteers aged between 18 and 65 years, both inclusive 2. healthy as judged by the principal investigator after medical history, physical examination, 12-lead ecg, laboratory tests (including hiv, hbsag and hepatitis c antibody tests) and assessments of pulse rate and blood pressure 3. ability to use a turbuhaler according to the provided instructions, as judged by the principal investigator or the study nurse 4. have a body mass index (bmi) between 18 and 30 kg/m2 inclusive and weighing at least 50 kg and no more than 100 kg - exclusion criteria: 1. history or presence of respiratory, gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs (except for cholecystectomy) 2. current smokers or those who have smoked or used nicotine products within the previous 3 months should be excluded 3. plasma donation within 1 month of screening or any blood donation or blood loss of more than 500 ml during the 3 months prior to screening 4. history of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the principal investigator or history of hypersensitivity to terbutaline (or drugs of a similar chemical structure or class) or inhaled lactose 5. positive screen for drugs of abuse and/or alcohol and/or cotinine at screening (visit 1) or on admission to the study centre (day -1) prior to administration of the investigational medical product (imp) on day 1 -

Keywords: healthy volunteers, pharmacokinetic, inhalation
a bioequivalence study to compare the pharmacokinetics (pk) of marketed product tobradex® to an experimental ophthalmic sterile ointment containing tobramycin and dexamethasone in aqueous humor in patients undergoing indicated cataract surgery

Conditions: Bilateral Cataract

Summary: each patient will be randomized to receive one dose of the test article in one eye and one dose of the reference formulations in the contralateral eye. one eye will be selected as the initial eye for cataract surgery and aqueous humor collection and hence will be dosed and operated on first. followed by the second eye which will be dosed no early than a week followed by aqueous humor collection as per specified time points and no later than 35 days following the first eye again prior to the cataract surgery.


Eligibility criteria:
inclusion criteria: * be male or female 18 years of age and above * presence of visually significant cataracts in both eyes * have a chief complaint consistent with visually significant cataracts * be able to communicate effectively with the study personnel and be able to understand and follow directions * be medically fit with clinically acceptable laboratory profiles and ecg * be willing to carry out the required pre op directions and post op care and be able to make the scheduled appointment * have given the written informed consent for participation in the study * in addition, female patients of child bearing potential age must have a negative urine pregnancy test exclusion criteria: * participation in any ophthalmic indicative bioavailability/ bioequivalence/ pharmacokinetic study or received an ophthalmic indicative investigational drug within a period of three months prior to screening * presence or history of recent viral corneal disorder or active corneal condition which is contraindicated. * presence or history of uveitis or uveitis * presence of retinal disorders * ocular trauma within three months of the trial * patients who had received topical and or systemic/ oral steroids * uncontrolled diabetes * history of any allergies * known hypersensitivity or allergy to tobradex® in combination or its components * clinical laboratory test values outside the acceptable reference range and when confirmed on re-examination deemed to be clinically significant as determined by the investigator(s) * clinically significant illness during 3 weeks prior to visit 1 (as determined by the investigators) * presence of a clinically significant systemic disorder
prevalance of non_ alcoholic fatty liver diseases in patient with inflammatory bowel diseases attending assiut university hospitals

Conditions: Inflammatory Bowel Disease Patients

Summary: to assess the prevalance of non_alcoholic fatty liver diseases in inflammatory bowel disease patients and its relation to type of treatment given and disease severity

inflammatory bowel diseases (ibd) including crohns disease (cd) and ulcerative colitis (uc) are chronic relapsing disorders that often require long-term therapy and follow up . they are recognized for their complex pathophysiology that involves innate immune system deregulation and altered microbiome in genetically predisposed individuals. non-alcoholic fatty liver disease (nafld) includes a wide spectrum of disorders, ranging from hepatic steatosis (nafl) to non-alcoholic steatohepatitis (nash). nafld patients are at high risk for liver fibrosis, cirrhosis, and hepatocellular carcinoma (hcc). also nafld is typically associated with altered metabolism and metabolic syndrome (mets).

Eligibility criteria:
inclusion criteria: * crohn's disease (cd) patients * ulcerative colitis (uc) patients exclusion criteria: * diabetic patients * bmi equal and more than 30.0-34.9(class i obesity)